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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Non-Powered
510(k) Number K910225
Device Name BONE PAD REMOVER
Applicant
ACRA CUT, INC.
989 MAIN ST.
ACTON,  MA  01720
Applicant Contact JOHN W BAKER
Correspondent
ACRA CUT, INC.
989 MAIN ST.
ACTON,  MA  01720
Correspondent Contact JOHN W BAKER
Regulation Number882.4535
Classification Product Code
HAO  
Date Received01/18/1991
Decision Date 02/12/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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